Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03964480|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 9, 2020
This study T-Cell Project 2.0 is based on the former International PTCL study designed by the International T-cell Non-Hodgkin's Lymphoma Study Group (T-Cell Project 1.0: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma) as a prospective collection of data to predict the prognosis of patients with the more frequent subtypes of PTCL. It is a prospective, longitudinal, international, observational study of patients with newly diagnosed peripheral T-cell lymphoma aiming to verify whether this prospective collection of data would allow achieving a more accurate information on T-cell lymphomas.
The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population as well as molecular markers and to explore the prognostic or predictive implications of them in PTCL.
The study aims to better define the clinical relevance of the new WHO Classification, the role of FDG-PET in staging and response assessment, the prognosis of different entities, the genomic landscape of different subtypes, and to investigate on most optimal treatment strategies for these neoplasms in the real-world population.
|Condition or disease|
|Peripheral T-Cell Lymphoma|
Peripheral T-cell non-Hodgkin lymphomas (PTCLs) are a heterogeneous group of lymphoproliferative disorder arising from mature T cells of post-thymic origin at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentation. All subtypes are found more commonly in male patients, and the median age at diagnosis is 62 years. This disease is generally associated with high relapse rates and a poor prognosis, with inferior treatment outcomes compared with B-cell lymphomas and have a 5-year-survival < 32%.
T-cell lymphomas are widely recognized as a complex and heterogeneous group of lymphoproliferative disorders, generally associated with high relapse rates and a poor prognosis. Because of their rarity, they are still very poorly understood.
The introduction of new and more effective therapies and better technologies led the International T-cell non-Hodgkin's Lymphoma Study Group to launch the T-cell Project 2.0 in order to have a contemporary, real-time understanding of the T-cell lymphoma biology and treatment, together with the application of contemporary technologies to further identification of new therapeutic targets.
Per protocol, patients are evaluated according to the treating physician's standard practice. There are no specific evaluations or visits required for the Registry. Data captured in the Registry reflects what is routinely collected for patients with PTCL.
The study plans to collect the tissue sample for central review. The ordinary fixation, cryopreservation and routine tumor cytogenetics are planned for biopsy samples. Chairmen of the Histopathology Review Panel will locate Regional sites where expert hematopathologists will review the material and perform a panel of immunostains (T-cell panel + CD20) and markers not assessed at local site.
Adding of blood sample collection will allow estimating prospectively the frequency of pEBVd detection in our cohort of PTCL patients at baseline and at the end of initial therapy, to characterize agreement between pEBVd and EBER in tumor tissue, and to explore the prognostic or predictive implications of detectable pEBVd in PTCL. Finally, to investigate the genetics and pathogenic mechanisms of aggressive PTCLs on an international scale.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.|
|Actual Study Start Date :||October 14, 2018|
|Estimated Primary Completion Date :||January 30, 2023|
|Estimated Study Completion Date :||July 30, 2025|
- Progression-free survival (PFS) [ Time Frame: 2 year ]Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
- Overall Survival (OS) [ Time Frame: 3 and 5 year ]Measured from the date of diagnosis until death from any cause
- Progression-Free Survival (PFS) [ Time Frame: 3 and 5 years ]Measured from the date of diagnosis until the date of disease progression or death from T-cell Lymphoma
- Event Free Survival (EFS) [ Time Frame: at 24 months ]Measured from the date of diagnosis until the date of event
- Complete Response Rate (CR) [ Time Frame: at 30 months ]Complete response rate at 30 months (CR30) after enrollment (i.e., initiation of treatment)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964480
|Contact: Martina Manni, MSc, PhDfirstname.lastname@example.org|
|Contact: Monica Civallero, MSc, PhDemail@example.com|
|United States, California|
|Stanford University||Not yet recruiting|
|Stanford, California, United States, 94305|
|Contact: Ranjana Advani, MD 650-725-6456 firstname.lastname@example.org|
|Contact: Jessica Catherine Lam, MSc, PhD +16507230437 email@example.com|
|IRCCS Istituto Tumori "Giovanni Paolo II"||Recruiting|
|Bari, Italy, 70124|
|Contact: Attilio Guarini, MD 0039080/5555 905 firstname.lastname@example.org|
|Contact: Angela Monica Sciacovelli, PhD 0039080/5555 416 email@example.com|
|Palermo_La Maddalena||Not yet recruiting|
|Palermo, Italy, 90146|
|Contact: Maurizio Musso, MD 00 39 091-688 6801 firstname.lastname@example.org|
|Contact: Emilio Ianitto, MD 00 39 091-680 6603 email@example.com|
|Terni-Santa Maria||Not yet recruiting|
|Terni, Italy, 05100|
|Contact: Anna Marina Liberati, MD 00390744205971 firstname.lastname@example.org|
|Contact: Viviana Appolloni, PhD 00390744205971 email@example.com|
|Cluj Napoca_Ion Chiricuta Oncology Institute||Recruiting|
|Cluj Napoca, Romania, 400015|
|Contact: Ciprian Tomuleasa, MD 0040741337480 firstname.lastname@example.org|
|Contact: Catalin Vlad, MD 0040264598362 email@example.com|
|National Cancer Institute||Recruiting|
|Kiev, Ukraine, 03022|
|Contact: Iryna Kriachok, MD +380442572156 firstname.lastname@example.org|
|Contact: Tetiana Skrypets, MD +380502526606 email@example.com|
|Study Director:||Massimo Federico, MD||University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy|
|Principal Investigator:||Attilio Guarini, MD||U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"|
|Principal Investigator:||Julie Vose, MD||Section of Hematology/Oncology, Nebraska Medical Center, USA|
|Principal Investigator:||Steven Horwitz, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Miles Prince, MD||Peter MacCallum Cancer Center, Melbourne, Australia|
|Principal Investigator:||Kim Won Seog, MD||Hematology-Oncology Samsung Medical Center, Seoul, South Korea|
|Principal Investigator:||Dolores Caballero, MD||Instituto Biosanitaria de Salamanca, Salamanca, Spain|
|Principal Investigator:||Francesco Zaya, MD||Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy|
|Principal Investigator:||Stefano Luminari, MD||S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy|
|Principal Investigator:||Ranjana Advani, MD||Stanford University Medical Center, Stanford, CA, USA|
|Principal Investigator:||Andrei Shustov, MD||Seattle Cancer Care Alliance, Seattle, WA, USA|
|Principal Investigator:||Pierluigi Porcu, MD||Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA|
|Principal Investigator:||Astrid Pavlovsky, MD||Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina|
|Principal Investigator:||Carlos Chiattone, MD||Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil|
|Principal Investigator:||Francine Foss, MD||Yale University School of Medicine, New Haven, CT, USA|
|Principal Investigator:||Christopher Fox, MD||Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK|